Mr. Braley of Iowa
introduced the following bill; which was referred to the
Committee on Energy and
Commerce

A BILL

To enhance Food and Drug Administration oversight of
medical device recalls, to provide for the conditional clearance of certain
medical devices, and for other purposes.

1.

Short title

This Act may be cited as the
Medical Device Patient Safety
Act.

2.

Oversight of
device recalls by the Food and Drug Administration

(a)

Definitions

In
this Act:

(1)

Commissioner

The
term Commissioner means the Commissioner of Food and Drugs.

(2)

Device

The
term device has the meaning given that term in section 201(h) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).

(3)

Secretary

The
term Secretary means the Secretary of Health and Human
Services.

(b)

Actions by
Secretary

To enhance the oversight by the Food and Drug
Administration of device recalls, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall carry out the
activities described in this section.

(c)

Assessment of
device recall information

(1)

In
general

(A)

Assessment
program

The Secretary shall establish a program to routinely and
systematically assess—

(i)

information
submitted to the Secretary pursuant to a device recall order under section
518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e));
and

(ii)

information
required to be reported to the Secretary regarding a correction or removal of a
device under section 519(g) of such Act (21 U.S.C. 360i(g)).

(B)

Use

The
Secretary shall use the assessment of information described under subparagraph
(A) to proactively identify strategies for mitigating health risks presented by
defective or unsafe devices.

(2)

Design

The
program under paragraph (1) shall be designed, at a minimum, to
identify—

(A)

trends in the
numbers and types of device recalls;

(B)

the types of
devices in each device class that are most frequently recalled;

(C)

the causes of
device recalls;

(D)

the length of time
needed for a person subject to a device recall to complete the recall;

(E)

the length of time
needed for the Secretary to terminate a device recall;

(F)

whether the
Secretary has performed a device recall audit check;

(G)

which persons have
been subject to the most device recalls; and

(H)

any other
information as the Secretary determines appropriate.

(d)

Audit check
procedures

The Secretary shall clarify procedures for conducting
device recall audit checks to improve the ability of investigators to perform
these checks in a consistent manner.

(e)

Assessment
criteria

The Secretary shall develop explicit criteria for
assessing whether a person subject to a recall order under section 518(e) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or to a
requirement under section 519(g) of such Act (21 U.S.C. 360i(g)) has performed
an effective correction or removal action under such section 519(g).

(f)

Termination of
recalls

(1)

In
general

The Secretary shall document the basis for the
termination by the Food and Drug Administration of—

(A)

an individual
device recall ordered under section 518(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360h(e)); and

(B)

the requirement on
a manufacturer or importer of a device to report any correction or removal
action for which a report is required to be submitted to the Secretary under
section 519(g) of such Act (21 U.S.C. 360i(g)).

(2)

Publication

(A)

In
general

The Secretary shall, with respect to each termination
described in paragraph (1), publish the documentation required under such
paragraph not later than 180 days after such termination.

(B)

Protection of
confidential information or trade secrets

Before public
disclosure of the documentation under subparagraph (A), the Secretary shall
delete from the documentation the following:

(i)

Any
information that constitutes trade secret or confidential commercial or
financial information.

(ii)

Any
personnel, medical, or similar information, including the serial numbers of
implanted devices, which would constitute a clearly unwarranted invasion of
personal privacy.

Notwithstanding any
other provision of law, the Secretary may conditionally clear for introduction
into interstate commerce for commercial distribution a medical device intended
for human use if such medical device is cleared pursuant to section
510(k).

(b)

Postclearance
requirements

As part of the conditional clearance under
subsection (a), the Secretary may impose the following:

(1)

The Secretary may
restrict the sale, distribution, or use of the device but only to the extent
that the sale, distribution, or use of the device may be restricted pursuant to
section 520(e).

(2)

The
Secretary—

(A)

may require
continuing evaluation and periodic reporting on the safety, effectiveness, and
reliability of the device for its intended use; and

(B)

shall, to the
extent the Secretary makes a requirement under subparagraph (A), state in the
clearance order the reason or purpose for such a requirement and the number of
patients to be evaluated and the reports required to be submitted.

(3)

The Secretary may
require a prominent display in the labeling of the device and in the
advertising of warnings, hazards, or precautions important for the device's
safe and effective use, including patient information such as information
provided to the patient on alternative modes of therapy and on risks and
benefits associated with the use of the device.

(4)

The
Secretary—

(A)

may require
maintenance of records that will enable the applicant to submit to the Food and
Drug Administration information needed to trace patients if such information is
necessary to protect the public health; and

(B)

shall, to the
extent the Secretary makes the requirement under subparagraph (A), require that
the identity of any patient be disclosed in records maintained under the
postclearance reporting requirements only to the extent required for the
medical welfare of the individual, to determine the safety or effectiveness of
the device, or to verify a record, report, or information submitted to the
agency.

(5)

The Secretary may
require maintenance of records for specified periods of time and organization
and indexing of records into identifiable files to enable the Food and Drug
Administration to determine whether there is reasonable assurance of the
continued safety and effectiveness of the device.

(6)

The Secretary may
require submission of periodic reports, at specified intervals, which reports
shall comply with the following:

(A)

Identify any of
the following changes:

(i)

New indications
for use of the device.

(ii)

Labeling
changes.

(iii)

The use of a
different facility or establishment to manufacture, process, or package the
device.

(iv)

Changes in
sterilization procedures.

(v)

Changes in
packaging.

(vi)

Changes in the
performance or design specifications, circuits, components, ingredients,
principle of operation, or physical layout of the device.

(vii)

Extension of the
expiration date of the device based on data obtained under a new or revised
stability or sterility testing protocol.

(viii)

A change that
does not affect the device's safety or effectiveness.

(B)

Contain a summary
and bibliography of the following information not previously submitted:

(i)

Unpublished
reports of data from any clinical investigations or nonclinical laboratory
studies involving the device or related devices and known to or that reasonably
should be known to the applicant.

(ii)

Reports in the
scientific literature concerning the device and known to or that reasonably
should be known to the applicant. If, after reviewing the summary and
bibliography, the Food and Drug Administration concludes that the agency needs
a copy of the unpublished or published reports, the Food and Drug
Administration shall notify the applicant that copies of such reports should be
submitted.

(C)

Identify changes
made pursuant to an exception or alternative granted under section 801.128 or
809.11 of title 21, Code of Federal Regulations.

(7)

The Secretary may
require batch testing of the device.

(8)

The Secretary may
provide for any other requirements determined by the Secretary to be necessary
to provide reasonable assurance, or continued reasonable assurance, of the
safety and effectiveness of the device.

(9)

The Secretary may
require device tracking as provided under part 821 of title 21, Code of Federal
Regulations.

(c)

Rescission of
conditional clearance

The Secretary may rescind the conditional
clearance of a medical device under subsection (a) if the Secretary determines
that the conditions imposed on the clearance of the device described in
subsection (b) have not been
met.

.

(b)

Civil monetary
penalties

Section 303(f)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)(1)(A)) is amended by inserting , or a
regulation promulgated or an order issued to carry out this Act, after
any person who violates a requirement of this Act.

(c)

Process for the
review of device applications

Section 737(8)(J) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379i(8)(J)) is amended by inserting
or required as a condition of clearance of a device under section
510A after Act.

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